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Is Big Pharma set to corner the American market on medical marijuana?

The American Independent has previously reported on the growing corporatization of the incipient medical marijuana industry at a time when medical marijuana dispensaries scrabble to hold on to their businesses in the face of a multi-pronged federal crackdown. But there are signs afoot that it just may become ever more corporate if a Big Pharma push to get the U.S. Food and Drug Administration to recognize a cannabis-derived drug is successful.

Last week, British prescription drug manufacturer GW Pharmaceuticals announced a licensing agreement with drug giant Novartis, maker of Ritalin and Excedrin, to begin selling GW’s drug Sativex in markets across Asia, Africa, Oceania and the Middle East. The medication is already available in Britain, where it’s produced and marketed by Bayer, and in Canada and Spain. It’s on the market in those countries as a liquid that patients spray under the tongue and is prescribed primarily for sufferers of multiple sclerosis and cancer.

Sativex: Liquefied marijuana

If the name “Sativex” rings a distant bell, that’s because it’s derived from Cannabis sativa, the scientific name for the plant from which both hemp and marijuana are harvested. It’s an appropriate name because, unlike other cannabinoids produced for recreational and medicinal use (and plagued by side effects not present in natural cannabinoids), Sativex is not a synthetic concoction, but essentially liquefied marijuana. It’s an extract of whole-plant cannabis that includes the psychoactive agent THC as well as cannabidiol (CBD), the chemical thought to be responsible for some of the anti-nausea and cancer-cell-killing effects of medical marijuana.

While the official word from GW is that the THC and CBD balance each other out to provide marijuana’s medicinal effects without an accompanying high, cannabis expert and professor emeritus of psychiatry at Harvard Medical School Dr. Lester Grinspoon has said just upping the dosage would provide the same effects as recreational marijuana.

Early in Sativex’s development, GW hired Dr. Andrea Barthwell as a consultant to sing the drug’s praises, although she’s no longer in the employ of GM. Barthwell was a deputy drug czar under George W. Bush and is the former president of the American Society for Addiction Medicine (ASAM). In a recent ASAM press release, Barthwell denounced medical marijuana but — significantly — only because it was unregulated by the federal government.

“The safety and advisability of any prescriptive medicine should depend on years of careful scientific scrutiny, not whims at the ballot box by individuals who lack the qualifications to make such decisions. Allowing cannabis to circumvent FDA approval sets a dangerous precedent and puts us on a slippery slope,” Barthwell says in the release.

“There’s certainly an inconsistency in the fact that she speaks publicly about the negative impact of marijuana even though she’s been paid by a company that sells it,” says Steve Fox, chief lobbyist for the National Cannabis Industry Association (NCIA). “It would be one thing if she were representing the American Society Against Bronchitis and said, ‘I am so concerned that people are smoking a substance that’s not good for their bronchial tubes.’ But she’s speaking for the ASAM.”

Meanwhile, Sen. Richard Burr (R-N.C.), Congress’s top recipient of campaign funds from the pharmaceutical industry, has come out against state medical marijuana laws, despite being an advocate of states’ rights on issues like allowing offshore drilling. The likes of Barthwell and Burr have drawn the ire of supporters for the reform of marijuana laws who believe that they represent the pharmaceutical industry’s goal for medical marijuana: demonize it, prosecute it, shut it down, then grab the market.

(Neither Barthwell nor Burr was available to comment for this story at the time of publish.)

Certainly, such a fight would benefit from proclamations like Barthwell’s distinction between government-approved drugs derived from cannabis and unregulated cannabis itself, as well as the National Cancer Institute’s recognition (later qualified) of the medical benefits of marijuana. That could be exactly what GW is banking on as it works with companies to expand the availability of Sativex around the world. And the one major market left untapped by either Novartis or Bayer (GW’s partners in making and selling Sativex) is the United States. That’s where Otsuka Pharmaceutical comes in.

Otsuka, America’s potential Sativex supplier

Otsuka is an international prescription drug company based out of Japan. In 2007, GW and Otsuka announced that the latter company would be taking on clinical trials for Sativex in the U.S. In November of last year, Otsuka wrapped up its Phase II trials testing the drug’s efficacy and safety and met with the FDA to discuss the next step in getting the drug recognized by the federal agency. Phase III was then set to begin, though Otsuka’s website for the Phase III trials indicates that they’re still being set up.

Otsuka declined to comment to The American Independent on how close Sativex is to FDA approval or how far along the Phase III trials are, but Phase III is typically the final step in a drug’s path to pharmacies. Even getting to Phase III means the FDA has signed off on earlier test results and needs to see them confirmed in a large-scale study before advancing the drug. For its part, the FDA does not comment on ongoing clinical trials.

Pharmaceutical insiders would claim that Sativex is simply a regulated, tested cannabinoid that is demonstrably safe in ways that black-market and state-legal whole-plant medical marijuana isn’t. And yet by its very definition (PDF), Sativex is marijuana, albeit with a lower THC count in the recommended dose than is present in the raw plant.

Can pharmaceutical clout bring FDA approval?

So how are pharmaceutical companies looking to succeed where medical marijuana dispensaries are failing in getting marijuana recognized by the FDA without any federal agencies breathing down their necks? One answer could be in the clout the industry holds in Washington.

The pharmaceutical industry is far and away the biggest spender on federal lobbying. Between 1998 and 2010, Big Pharma spent more than $2 billion sending lobbyists to the capital to fight for industry-friendly legislation and regulations. This is over half a billion more than the amount spent in the same period by pharmaceuticals’ closest competitor, the insurance industry, and nearly twice what oil and gas companies spent. The medical marijuana lobby, less than six months old and consisting almost entirely of Steve Fox (backed by NCIA director Aaron Smith and a handful of dispensary owners and enthusiasts), could never compete.

All this puts the surging federal clampdown on medical marijuana in a new light. As nationwide support for medical marijuana reaches record levels, it may just be the pharmaceutical industry that rides that wave of support to huge profits.

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Here is another take on the same subject. This says big pharma is about to take over the medical marijuana market.

Big Pharma Set to Take Over Medical Marijuana Market

Just as the federal government is clamping down on medical marijuana dispensaries, the Federal Drug Administration (FDA) may be set to give Big Pharma the clearance to take over the market.

In 2007, GW Pharmaceuticals announced that it partnered with Otsuka to bring "Sativex" -- or liquefied marijuana -- to the U.S. The companies recently completed Phase II efficacy and safety trials testing and began discussion with the FDA for Phase III testing. Phase III is generally thought to be the final step before the drug can be marketed in the U.S.

"GW Pharmaceuticals plc (AIM: GWP) today announces the initiation of the Phase III clinical trials programme of Sativex in the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy," GW said in a statement. "This indication represents the initial target indication for Sativex in the United States."

Sativex is the brand name for a drug derived from cannabis sativa. It's an extract from the whole plant cannabis, not a synthetic compound. Even GW defines the drug (.pdf) as marijuana.

Yet as the FDA is poised to approve the drug for Big Pharma, state-licensed medical marijuana dispensaries that provide relief for thousands of Americans are under attack by other federal agencies.

Lynette Shaw, the owner and founder of Marin Alliance for Medical Marijuana (MAMM) in Fairfax, California, was stunned when the IRS audited her 2008 and 2009 tax returns and disallowed the foundation's business deductions, then demanded millions of dollars in back taxes.

The IRS pursued her under § 280E of the federal tax code, which states that no business deductions will be allowed for companies "trafficking in controlled substances".

Shaw is now suing the IRS to prevent them from destroying the entire medical marijuana industry.

Last week, the Justice Department even threatened to prosecute state employees who license medical marijuana dispensaries.

As a result, Washington state Gov. Chris Gregoire (D) said she would veto a bill that would have allowed the state to license growers.

"The DEA's intent is to expand the federal government's schedule III listing to include pharmaceutical products containing naturally derived formations of THC while simultaneously maintain existing criminal prohibitions on the plant itself," Paul Armentano, the deputy director of the National Organization for the Reform of Marijuana Laws (NORML), wrote at AlterNet.